Study of the Effects of BMS-919373 on the Electrical Activity of the Heart Using Pacemakers

Atrial Fibrillation Clinical Trial

Official title:

A Study of the Effects of BMS-919373 on Atrial Effective Refractory Period in Subjects With a Dual-Chamber Pacemaker

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02153437
• Other study ID #: CV205-006
• Status: Terminated
• Phase: Phase 1
• Start date: October 30, 2014
• Est. completion date: October 20, 2016

Study information

• Verified date: December 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the effect of our compound (BMS-919373) on electrical activity of the heart using pacemakers.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: October 20, 2016
• Est. primary completion date: October 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria

• Age 18 years to 85 years.

• Eligible patients will have a dual-chamber permanent pacemaker.

• Women who are not of childbearing potential.

Exclusion Criteria

• Patients with a history of Atrial Fibrillation (AF) that is either:.

i) Permanent (i.e. patients are only in AF and never in sinus rhythm) or.

ii) Persistent (i.e. patients who's episodes of AF are longer than 7 days and require medical intervention, such as electrical or medical cardioversion, to return to sinus rhythm), are excluded.

• History of Transient Ischemic Attack (TIA) or stroke in the last 12 months.

• History of clinically significant ventricular arrhythmia (not including isolated monomorphic Premature Ventricular Contractions (PVCs)). Such arrhythmias are marked by loss of consciousness, emergent cardioversion or defibrillation or unstable vital signs requiring medical intervention.

• Complete heart block.

• Planned surgery, endovascular intervention or cardioversion within the study period.

• History of atrial fibrillation.

• Other protocol-defined Inclusion/Exclusion criteria apply.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• BMS-919373

• Sotalol

• Placebo for BMS-919373

Locations

Country	Name	City	State
Canada	The University Of Calgary	Calgary	Alberta
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution - 0002	Montreal	Quebec
Canada	University Of Ottawa Heart Institute	Ottawa	Ontario
Canada	Local Institution - 0001	Toronto	Ontario
United States	Local Institution	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of BMS-919373 on Atrial effective refractory period (AERP) in subjects with a dual chamber pacemaker		At 0.5, 1, 2, and 4 hours following study drug administration
Secondary	The safety assessments will be based on Adverse event reports, vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests		At 1, 2, and 4 hours following study drug administration
Secondary	Safety assessments based on Ventricular Effective Refractory Period (VERP) and change from baseline		At 2 hour following study drug administration
Secondary	Safety assessments based on Atrioventricular interval (AVI) and change from baseline		At 1, 2, and 4 hours following study drug administration
Secondary	Safety assessments based on Wenckebach cycle length (WCL) and change from baseline		At 1, 2, and 4 hours following study drug administration
Secondary	Safety assessments based on Intra-atrial conduction time (IACT) and change from baseline		At 1, 2, and 4 hours following study drug administration

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls